Clearance Summary
IMLOGIX 1000 IMAGE DISPLAY SYSTEM received FDA 510(k) clearance under submission number K893521, sponsored by Imlogix A Div. of Microterm. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1989-06-23.
- Submission: K893521
- Applicant / Sponsor: Imlogix A Div. of Microterm
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1989-06-23
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.